A stability-indicating gradient UPLC method was developed to separate Rasagiline and all its potential impurities in Azilect Tablets, which use Rasagiline mesylate as active pharmaceutical ingredient (API). Experimental design was applied during the method optimization and robustness testing (Full factorial 23 design). The method was developed using Waters Aquity BEH phenyl column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 210 nm. The run time was 9 min within which Rasagiline mesylate and its nine impurities were well separated. Rasagiline mesylate  was  subjected  to  the  stress  conditions  of  oxidative,  acid,  base,  hydrolytic,  thermal  and photolytic degradation. Rasagiline mesylate was found to degrade in oxidative stress conditions and stable in acid, base, hydrolytic, Thermal and photolytic degradation conditions.  The degradation products were well resolved from main peak and its impurities, thus proved the stability-indicating power of the method.  The  developed  method  was  validated  as  per  ICH  guidelines  with  respect  to  specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.

Use of experimental design in the rapid separation of Rasagiline and its potential impurities in solid pharmaceutical formulation using UPLC

248th National Meeting (2014)

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